Actively Recruiting
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With HER2+ Locally Advanced and/or Metastatic Solid Tumors
Led by China Medical University, China · Updated on 2024-03-06
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
China Medical University, China
Lead Sponsor
S
Shanghai First Song Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating anti-HER2-CAR-T cell therapy in adults aged 18 to 70 years with HER2-positive locally advanced or metastatic solid tumors, including breast, gastric, colorectal, and pancreatic cancers. This Phase 1, open-label study aims to assess the safety and effectiveness of this cellular treatment when conventional options have been ineffective or are not tolerable. The trial is sponsored by China Medical University, China. Participants receive a single intravenous infusion of anti-HER2-CAR-T cells at varying doses based on a dose escalation design, with possible additional infusions decided by the investigator. Before infusion, patients undergo lymphocyte clearance treatment using cyclophosphamide and fludarabine. Treatment dosing groups include 1x10^6, 3x10^6, or 1x10^7 CAR-T cells per kilogram, and the infusion dose refers to the count of CAR-positive cells. During the study, participants will have an initial screening period, mononuclear cell collection, and may receive bridging therapy if needed before treatment. Researchers will monitor safety by tracking dose-limiting toxicities within 21 days post-infusion and evaluate tumor responses at multiple timepoints up to 12 months. Assessments include imaging for measurable lesions, blood tests, and overall health status. The study includes close follow-up and may last until October 2026.
CONDITIONS
Brief Title
A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who understand and sign informed consent forms and voluntarily participate
- Age 18 to less than 70 years, any gender
- Locally advanced and/or metastatic solid tumors with HER2-positive expression in tumor tissues
- Histology-confirmed solid tumors where conventional treatment is ineffective, not tolerated, or lacking
- At least one measurable lesion with a maximum diameter not exceeding 6 cm according to RECIST v1.1
- Expected survival of at least 12 weeks
- ECOG performance status score of 2 or less
- Adequate blood cell counts and no blood transfusion or growth factor within 7 days before screening
- Adequate liver function within defined limits
- Adequate kidney function with creatinine clearance ≥50 mL/min
- Left ventricular ejection fraction (LVEF) of at least 50%
- No breathing difficulty at rest or pulse oximetry above 90% on room air
- Sufficient intravenous access for blood cell collection and no contraindications
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception during and 6 months after treatment
You will not qualify if you...
- Previous use of any CAR-T cell or other genetically modified T cell therapies
- Waiting for or history of organ or stem cell transplantation
- Acute or uncontrolled active infections including tuberculosis
- Positive infection markers for hepatitis B, hepatitis C, syphilis, or HIV
- Low blood sodium (<125 mmol/L) or potassium (<3.5 mmol/L) unless corrected
- Liver tumor replacement ≥50% by imaging
- Use of systemic steroids above specified doses within defined periods before treatment
- Recent immunosuppressive or immunostimulatory therapy or antibody therapy before apheresis
- Radiotherapy within 28 days before apheresis except limited local palliative
- Other malignant tumors within past 5 years except certain controlled cancers
- Active ulcers or difficult-to-control gastrointestinal bleeding
- History of central nervous system tumors or diseases affecting safety
- Uncontrolled cardiovascular or respiratory diseases
- Active or past autoimmune diseases except specified exceptions
- Serious systemic diseases or complications affecting safety or compliance
- Recent major surgery or trauma not fully recovered
- Allergy or intolerance to preconditioning or symptomatic treatment drugs
- Participation in other interventional trials within 1 month
- Pregnant or lactating women
- Unwillingness or inability to use contraception or comply with protocol
- Persons involved in study planning or execution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days within anti-HER2-CAR-T cell infusion
Participants receive lymphocyte clearance therapy followed by a single intravenous infusion of anti-HER2-CAR-T cells. Additional infusions may be given based on the investigator's decision.
1 baseline visit and multiple follow-up visits during 21 days
Duration - Up to 12 months after anti-HER2-CAR-T cell infusion
Participants are monitored for treatment response and safety with assessments at multiple time points after infusion.
Visits at 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 12 months
Trial Site Locations
Total: 1 location
1
Phase I Clinical Trials Center Of The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
S
Shuhui Song, bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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